Clinical news roundup: 1 June

Genentech has announced positive results from the pivotal Phase III GALLIUM study in people with previously untreated follicular lymphoma. The study compared the efficacy and safety of Gazyva (obinutuzumab) plus chemotherapy followed by Gazyva alone, head-to-head with Rituxan (rituximab) plus chemotherapy followed by Rituxan alone. Results from a pre-planned interim analysis showed that Gazyva-based treatment significantly reduced the risk of disease worsening or death compared to Rituxan-based treatment. Adverse events with either Gazyva or Rituxan were consistent with what was seen in previous clinical trials when each was combined with various chemotherapies.

Almac Discovery and the McClay Foundation are to fund a two year research collaboration with Ulster University to investigate if a specific type of protein could help to treat diseases of the eye. A form of the protein, which can reduce the growth or formation of blood vessels, is currently in clinical development by Almac Discovery as a cancer treatment. Using state-of-the-art technologies, including gene editing, Ulster University's Professor Tara Moore and her team of researchers will closely examine the effects of the protein, known as FKBP-L, after it is administered to the eye.

Mundipharma EDO (Early Development in Oncology) has initiated a first-in-human clinical trial of its investigational drug candidate EDO-S101, a first in class 'fusion molecule' for the treatment of relapsed-refractory (RR) haematological malignances. EDO-S101 is the first representative of the A-DAC principle, a new approach in chemotherapy that uses fusion technology to combine an alkylating agent with a pan-histone deacetylase inhibitor (HDAC) to simultaneously damage DNA and block damage repair. The combination of the two different modes of action has the potential to overcome resistance towards other conventional chemotherapies.

Researchers at the University of Dundee's School of Life Sciences have discovered that Otsuka's Deltyba (delamanid), which was recently approved for the treatment of tuberculosis, can cure a mouse model of visceral leishmaniasis at oral doses that may be achievable in patients. Visceral leishmaniasis is a disease which particularly affects the developing world with 200,000 to 400,000 new cases and 48,000 deaths annually.

A drug for breast cancer that is more effective than existing medicines may be a step closer thanks to new research. Scientists from the University of Edinburgh have identified a chemical compound that is highly effective at blocking the growth of breast cancer cells in the laboratory. The compound – called eCF506 – targets a molecule called Src tyrosine kinase that is required for breast cancer cells to grow and spread. Drugs that target the same molecule are already being tested in clinical trials. Researchers say eCF506 is different because it is more selective and doesn't affect other molecules in the cell. This may mean it will be more effective and have fewer side effects than the other drugs in development but further studies are needed.

An approach that could reduce the chances of drugs failing during the later stages of clinical trials has been demonstrated by a collaboration between the University of Cambridge and GSK. The technique involves identifying genetic variants that mimic the action of a drug on its intended target and then checking in large patient cohorts whether these variants are associated with risk of other conditions, such as cardiovascular disease. By analysing genetic variations in DNA encoding drug targets for type 2 diabetes and obesity in almost 12,000 individuals, the researchers identified a variant in the GLP1R gene that was associated with lower fasting glucose and a lower risk of type 2 diabetes – in other words, the variant appeared to mimic the action of the diabetes drugs. The researchers then used genetic data available through an international data-sharing consortium to study the association of that same variant with coronary heart disease in almost 62,000 individuals with coronary heart disease and over 160,000 controls. In fact, they found that the variant actually reduced the risk of heart disease. Long-term large-scale randomised controlled clinical trials to evaluate the cardiovascular safety of GLP1R-agonists are underway and results from a large trial are scheduled to be released later this month.